Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Bronchial Allergen Challenge Study to Assess the Safety, Tolerability, and Efficacy of Inhaled AIR645 in Subjects With Mild Allergic Asthma
1 other identifier
interventional
30
1 country
3
Brief Summary
To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Oct 2009
Shorter than P25 for phase_2 asthma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2009
CompletedFirst Posted
Study publicly available on registry
July 17, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 23, 2010
July 1, 2010
7 months
July 15, 2009
July 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo
36 days
Study Arms (2)
AIR645
EXPERIMENTALAIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
Physiologic saline solution
PLACEBO COMPARATORPhysiologic saline solution
Interventions
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Eligibility Criteria
You may qualify if:
- Men and women with well controlled mild allergic asthma, aged 18 to 65 years
- Only asthma med is short-acting bronchodilator used not more than twice weekly
- FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Laval, Quebec, Canada
Unknown Facility
Saskatoon, Saskatchewan, Canada
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Mike Hodges, MD
Altair Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 15, 2009
First Posted
July 17, 2009
Study Start
October 1, 2009
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
July 23, 2010
Record last verified: 2010-07